跳至主要内容
临床试验/NCT02692092
NCT02692092招募中不适用

HealthEast Community Hip and Knee Replacement Registry

HealthEast Care System1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 1991年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200,000
试验地点
1
主要终点
Cumulative Revision Rate

研究概览

简要总结

HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community.

As it moves into the third decade, the HJRR is proud of its role in the development of the national American Joint Replacement Registry (AJRR) and will remain an important contributor to the larger national effort in the advancement of orthopaedic science.

详细描述

HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, with a database that allowed tracking of implant use and failure rates among the 90 orthopaedic surgeons performing arthroplasty surgery in the greater metropolitan area of St. Paul, MN. Initially conceived as part of a process to better manage costs and determine which implants were most cost-efficient, it became apparent that the registry would allow insight into the same process that had proven its value in the Scandinavian joint registries. With the knowledge that a majority of total joint arthroplasties in the U.S. are performed by relatively low-volume community surgeons, the HJRR remains uniquely positioned to reflect contemporary U.S. surgical practices.

The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community. With the primary outcome measure of time to revision surgery, combined with analysis of confounding factors and mortality monitoring, the HJRR can provide some realistic measure of the success of a given arthroplasty procedure in our community. In addition, the registry can evaluate the relative effectiveness of different prosthetic designs, identify patient variables that may impact implant survival, and provide the tracking mechanism necessary in the event of implant recalls.

Over the 20 years of its existence, the HJRR has refined its data-gathering, data verification, and data analysis and utilizes a process design that requires no direct surgeon involvement with data input. Volunteer surgeons review each revision chart and operative note to carefully delineate the reason for revision. The HJRR capture process has been validated and more than 94% of the revision surgery is performed within the HJRR. The database is used to generate information of practical use to the surgeon, and has been demonstrated to influence surgeon behavior. Among other examples, HJRR reports on the failure rates associated with unicompartmental knee arthroplasty, hybrid and cementless total knee arthroplasty, and metal-on-metal total hip designs have led to significant declines in their respective use over the periods documented. Similarly, the HJRR allowed for rapid notification of surgeons and expedited patient care during the three significant hip implant recalls of the last decade.

As it moves into the third decade, the HJRR is proud of its influential role in the development of the national American Joint Replacement Registry (AJRR) as one of the earliest participants and pilot hospitals. It will remain an important contributor to the larger national effort, particularly for certain data subsets that may be outside of the scope of the much larger AJRR. The HJRR core workgroup has published widely on its findings in the last two decades, and looks forward to the future as a compelling example of how worthwhile information and advancements in orthopaedic science can be made in the community setting.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Total Hip or Total Knee Arthroplasty
  • HealthEast acute care hospital

排除标准

  • Primary procedure not performed at a HealthEast hospital

结局指标

主要结局

Cumulative Revision Rate

时间窗: 10 Years

Our end point of interest was revision for any reason, with revision defined as removal, exchange, or addition of components, requiring a second surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验